IRB Application Process

All research conducted at Saint Xavier University which involves human or animal subjects
must first be reviewed by the Institutional Review Board (IRB). The mission of IRB
is to assure that ethical guidelines for research are followed. IRB reviews each research
proposal and will either approve the proposal or make a formal request for changes
to meet ethical guidelines for human subjects research stated by the Collaborative
Institutional Training Initiative (CITI), and/or American Psychological Association
(APA). In cases of animal or other sensitive research, the proposal will be reviewed
by the entire IRB committee. The committee consists of faculty members representing
all four schools, the broader professional community, and the general public.

Applications for review of proposed human subjects research are accepted by the IRB
at any time. During the academic year, complete applications are reviewed by the committee with goals of two-week turn-around times
for applications qualifying for expedited review and four-week turn-around times for
applications requiring full review. Please email the IRB Committee Chair with your Intention to submit a proposal. This email "intent to submit" notification of allows you to be enrolled in the IRB Submission Canvas course. Once you are enrolled in the Canvas course, please follow the instructions to submit the IRB proposal.

All applicants should use the IRB Application Form (DOC) and make sure to complete the key steps in preparing an IRB application noted
on this page. Applicants are encouraged to consult other pages of the IRB website
as well as handbooks for additional guidance on the design of research projects involving
human subjects and the preparation of related IRB applications that entail the use
of appropriate templates (consent forms, parent permission, institutional agreements,
etc.)

Complete IRB applications (including accompanying documents in ONE continuous PDF file) should
be submitted via the IRB Submission Canvas Course (again as a single PDF document). Additionally, you will need to print a hard copy
of the signature box page of the main application form and any administrator consent
forms, collect the required signatures, and upload these items as a part of the submission.
Complete submission instructions may be viewed on the Helpful Hints page. If you are a student, your faculty sponsor is responsible for reviewing and signing
your application forms for IRB review (and the consent form, if applicable) prior
to submission to the IRB.

After an initial review of the research protocol, an IRB member will contact the researcher
to inform him or her of the following:

The IRB may request additional information regarding the nature of the research protocol,
or

The IRB may require changes in the informed consent procedures or content. Proposals
are classified and processed by the IRB as exempt, as expedited review, or as requiring
full review based on the level of risk to human subjects, and on the adequacy of the
information and consent provided to the proposed research subjects.

The result of a review is either approval, non-approval, or a written request for
changes. Any changes made in response to such a request must be re-submitted in writing
(to the IRB Submission Canvas course and will be processed through the review again.

Via email, you will receive a formal letter from the IRB indicating their review of
your proposal, and you may begin data collection upon notification that your proposal
has been approved by the IRB.

In compliance with Sections 115 and 103.b.3-5 of 45 CFR 46, the IRB maintains records of IRB operations, applications to the IRB,
and decisions related to those applications. Records related to IRB applications that
are not approved are kept for 3 years after the date on which the decision was rendered,
and records pertaining to IRB applications that were approved are kept for 3 years
after the conclusion of the study.

Key Steps in Preparing an IRB Application:

Send an email to the IRB chair notifying them of your intent to submit a proposal.
Complete the IRB Application Form (DOC) (with all appropriate signatures). Once submitted, an IRB member will review and decide whether the proposal should
undergo an exempt, expedited, or full review process.

Outline your description of proposed project in the application form.

Attach any auxiliary materials (the questionnaire you plan to use, permission letters
from data collection sites, certification for CITI training) to the above documents
as one continuous PDF file.

All submissions must be done by a full-time faculty, or adjunct faculty members, the
application form should be reviewed and signed by a faculty member if the study is
student initiated. The faculty member should send the student copies of all correspondence
between the IRB committee and the faculty.

Faculty sponsors or researchers and all other project personnel, including student
researchers or assistants, must complete CITI: (1) Be sure to include with any submissions,
an electronic copy of the completed IRB application (DOC) and all auxiliary materials to the IRB Submission Canvas course (2) When appropriate, obtain a letter of agreement from a gatekeeper at the institution
that hosts your research and upload it as a part of application package to the IRB Submission Canvas course. Once you are enrolled in the Canvas course, please follow the instructions to submit the IRB proposal.

Applicants should allow ample time for processing, as IRB committee members' schedule,
the volume, and complexity of proposals fluctuates, and revisions and multiple rounds
of review may be necessary. However, within 2 business days of submission of a complete, clearly assembled application, applicants should receive an email from the IRB Chair/Co-Chair acknowledging receipt
of the complete IRB application and assigning a tracking number that should be used
in all correspondence related to the application. Be aware thatincomplete applications will not be reviewed, and target processing timelines only commence with receipt of a complete IRB application. If the IRB reviews an application and requires revisions to it, the relevant processing
timeline starts over upon the IRB's receipt of the revised application. Applicants
are encouraged to contact the IRB concerning the status of their applications if either
an acknowledgement of receipt coupled with issuance of a tracking number has not been
received within two business days of application submission, or following issuance
of a tracking number, the IRB has not made follow-up contact at the end of the relevant
processing period (2 weeks for expedited review and 4 weeks for full review). Be aware that data collection may not begin prior to receipt of IRB approval.